DeviceClearance

Product code CBK— Anesthesiology

GE DATEX-OHMEDA ENGSTROM CARESTATION

Classification name
Ventilator, Continuous, Facility Use
Device class
Class 2
Regulation
21 CFR 868.5895
Advisory panel
Anesthesiology
Total cleared
505
First cleared
Most recent

Market context for product code CBK

FDA has cleared 505 devices under product code CBK between 1976 and 2026, filed by 148 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code CBK

Adverse events under product code CBK

product code CBK
Death
736
Injury
3,628
Malfunction
98,786
Other
4
Total
103,154

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code CBK

1–100 of 505

Data sourced from openFDA. This site is unofficial and independent of the FDA.